Karesol 10mg film-coated Tablets

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

SOLIFENACIN SUCCINATE

Доступна з:

STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Germany

Код атс:

G04BD08

ІПН (Міжнародна Ім'я):

SOLIFENACIN SUCCINATE 10 mg

Фармацевтична форма:

FILM-COATED TABLET

Склад:

SOLIFENACIN SUCCINATE 10 mg

Тип рецепту:

POM

Терапевтична области:

UROLOGICALS

Статус Авторизація:

Withdrawn

Дата Авторизація:

2011-12-15

інформаційний буклет

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
Karesol 10 mg film-coated tablets
Solifenacin succinate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Karesol is and what it is used for
2. What you need to know before you take Karesol
3. How to take Karesol
4. Possible side effects
5. How to store Karesol
6. Contents of the pack and other information
1. WHAT KARESOL IS AND WHAT IT IS USED FOR
The
active
substance
of
Karesol
belongs
to
the
group
called
anticholinergics.
These
medicines are used to reduce the activity of an overactive bladder.
This enables you to wait
longer before having to go to the bathroom and increases the amount of
urine that can be
held by your bladder.
Karesol is used to treat the symptoms of a condition called overactive
bladder. These
symptoms include: having a strong, sudden urge to urinate without
prior warning, having to
urinate frequently or wetting yourself because you could not get to
the bathroom in time.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KARESOL
DO NOT TAKE KARESOL

if you are unable to pass water or to empty your bladder completely
(urinary retention).

if
you
have
a
severe
stomach
or
bowel
condition
(including
toxic
megacolon,
a
complication associated with ulcerative colitis).

if you suffer from the muscle disease called myasthenia gravis, which
can cause an
extreme weakness of certain muscles.

if
you
suffer
from
increased
pressure
in
the
eyes,
with
gradual
loss
of
eye
sight
(glaucoma).

if you are allergic to solifenacin or any o

Характеристики продукта

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Karesol 5 mg film-coated tablets
Karesol 10 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Karesol 5 mg film-coated tablet contains 5 mg solifenacin
succinate, equivalent to
3.8 mg solifenacin.
Each Karesol 10 mg film-coated tablet contains 10 mg solifenacin
succinate, equivalent to
7.5 mg solifenacin.
Excipient(s) with known effect
Lactose monohydrate 109.0 mg 104.0 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Each 5 mg tablet is a round, light-yellow tablet of approximately 8 mm
in length, debossed
with “390” on one side of the tablet.
Each 10 mg tablet is a round, light-pink tablet of approximately 8 mm
in length, debossed
with “391” on one side of the tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Karesol is indicated in adults for symptomatic treatment of urge
incontinence and/or increased
urinary frequency and urgency as may occur in patients with overactive
bladder syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, including the elderly_
The recommended dose is 5 mg solifenacin succinate once daily. If
needed, the dose may be
increased to 10 mg solifenacin succinate once daily.
_Renal impairment _
No dose adjustment is necessary for patients with mild to moderate
renal impairment
(creatinine
clearance
> 30 ml/min).
Patients
with
severe
renal
impairment
(creatinine
clearance ≤ 30 ml/min) should be treated with caution and receive no
more than 5 mg once
daily (see section 5.2).
_Hepatic impairment _
Page 2 of 11
No dose adjustment is necessary for patients with mild hepatic
impairment. Patients with
moderate hepatic impairment (Child-Pugh score of 7 to 9) should be
treated with caution and
receive no more than 5 mg once daily (see section 5.2).
_Paediatric population _
The safety and efficacy of solifenacin in children have not yet been
established. Therefore,
Karesol should not be used in children.
_Potent inhib